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LEAN Trial: Victoza Effective in Resolving NASH
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VIENNA — More overweight patients with nonalcoholic steatohepatitis treated with Victoza injections experienced resolved nonalcoholic steatohepatitis and reduced fibrosis worsening vs. patients who received placebo, according to findings presented at the 2015 International Liver Congress.
“One of the biggest killers in NASH is cardiovascular disease, so we need to focus on that as much as we do the liver,” Matthew J. Armstrong, BSc, MBChB, MRCP, of the NIHR Birmingham Liver Biomedical Research Unit, University of Birmingham, said during a press conference. “We feel the GLP-1 analog, liraglutide, gives you the whole package potentially of improving your liver disease while improving your cardiovascular risk at the same time.”
Matthew J. Armstrong
Armstrong and colleagues randomly assigned 52 patients with obesity and biopsy-proven NASH to receive a 48-week treatment with once-daily, subcutaneous injections of either 1.8 mg of Victoza (liraglutide, Novo Nordisk; n=26) or placebo (n=26). The primary outcome was the resolution of NASH and no worsening in fibrosis from baseline to end-of-treatment, according to the research.
“We hypothesized that treatment with a high dose of 1.8 mg of liraglutide injections would result in significant improvement in liver histology in patients with NASH,” Armstrong said in his presentation.
Forty-five patients underwent liver biopsy at the end of treatment. Of these patients, 39% of patients (9/23) who received liraglutide had resolved NASH with no worsening of fibrosis compared with 9% of the patients on placebo (2/22). Armstrong showed that 82.6% of patients showed improvement in fat content of the liver. Two patients who received liraglutide had worsening of fibrosis compared with eight patients on placebo. Also, liraglutide showed reduced weight, BMI and fasting glucose compared with placebo.
No drug-related serious adverse events were reported. However, two of 26 patients withdrew from treatment due to drug-related gastrointestinal side effects, such as nausea and diarrhea.
“Liraglutide met the primary end-point of histological clearance of NASH,” Armstrong said. “We feel it is well-tolerated with an acceptable safety profile with no drug-related serious adverse events. Phase 3 trials are now warranted for GLP-1 therapy in NASH.” – by Melinda Stevens
For More Information:
Armstrong MJ. Abstract G01. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Armstrong reports receiving an educational research grant and product in-kind from Novo Nordisk. Please see the study for a full list of other authors’ relevant financial disclosures.